effects of green tea extracts on gastric mucosal protection

Conditions: Functional Dyspepsia

Summary: the investigators conduct a randomized, double-blind, placebo-controlled pilot study to investigate the effects of a combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) on gastric mucosal protection in adults with functional dyspepsia for 8 weeks.

a previous study has indicated that combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) may improve gastric mucosal status in rat with alcohol-induced gastritis.therefore, the investigators conduct a randomized, double-blind, placebo-controlled pilot study to investigate the effects of a combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) on gastric mucosal protection in adults with functional dyspepsia for 8 weeks; the safety of the compound are also evaluated. the investigators examine c-reactive protein, ifn-γ, tnf-α, gastrin, malondialdehyde, 8-hydroxy-2' -deoxyguanosine, and questionnaires (gastrointestinal symptom rating scale, nepean dyspepsia index-korean version, nepean dyspepsia index-korean version qol questionnaire, gastrointestinal symptom scale) at baseline and after 8 weeks of intervention. twenty four adults were administered either 320 mg of combined extracts of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) or a placebo each day for 8 weeks.

Eligibility criteria:
inclusion criteria: * the rome iv criteria define dyspepsia as any combination of 4 symptoms: postprandial fullness, early satiety, epigastric pain, and epigastric burning that are severe enough to interfere with the usual activities and occur at least 3 days per week over the last 3 months exclusion criteria: * patients complaining of severe gastrointestinal symptoms requiring immediate medication * those with a history of gastric acid hypersecretion such as zollinger-ellison syndrome * those who received helicobacter pylori eradication therapy within 4 weeks * those who have taken nonsteroidal anti-inflammatory drugs, steroid drugs or antibiotics, aspirin or antithrombotic drugs, or gastric acid suppressants within 4 weeks * those who have a history of upper gastrointestinal tract surgery, stenosis, bleeding, esophageal dilatation, gastric mucosal resection, etc. within the past 1 year * patients with gastric ulcer (active or healing), duodenal ulcer (active or healing), reflux esophagitis (la b or higher), or malignant tumors from gastroscopy performed within the last 6 months * abnormal liver or renal function (more than twice the normal upper limit of the research institute) * uncontrolled diabetes mellitus (\>160 mg/dl of fasting blood sugar) * history of fracture during the previous year * uncontrolled hypertension (\>160/100 mmhg) * uncontrolled thyroid diseases. * history of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months * history of any central bone fracture within 1 year * history of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication. * alcohol abuser * allergic reaction to ishige okamurae * those who participated in other drug clinical trials within 1 month from the screening date. * severe gastrointestinal symptoms such as heartburn and indigestion * those who are pregnant, lactating, or plan to become pregnant during the clinical trial * those who are judged to be unsuitable by the pi for other reasons